🚑FDA Revokes Emergency Use Authorizations for COVID-19 Diagnostic Tests
Revocation of Three Authorizations of Emergency Use of In Vitro Diagnostic Devices for Detection and/or Diagnosis of COVID-19; Availability
Summary
The Food and Drug Administration (FDA) is announcing the revocation of the Emergency Use Authorizations (EUAs) (the Authorizations) issued to Beckman Coulter, Inc., for the Access SARS- CoV-2 IgG, Access SARS-CoV-2 IgM, and Access SARS-CoV-2 IgG II tests. FDA revoked the Authorizations under the Federal Food, Drug, and Cosmetic Act (FD&C Act) as requested by the Authorization holder. The revocations, which include an explanation of the reasons for each revocation, are reprinted at the end of this document.
Agencies
- Health and Human Services Department
- Food and Drug Administration
Business Impact
$$ - Med
The revocation of Emergency Use Authorizations (EUAs) for in vitro diagnostic tests indicates strict regulatory compliance requirements for businesses in the medical device sector. Companies must adapt to changes in authorization status, affecting product distribution and market strategy.